Data / Medical devices / United States / Trimed, Inc.
Trimed, Inc.: FDA-registered device maker in Santa Clarita, CA, United States, 40 510(k) clearances
Trimed, Inc. is registered with the FDA (registration 2031009) in Santa Clarita, CA, United States. It lists 28 device types. The FDA files 40 510(k) clearances under its listings, the newest dated August 12, 2026. 11 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2031009
- FEI number
- 3001236812
- Address
- 27533 Avenue Hopkins, Santa Clarita, CA, United States, 91355
- Owner or operator
- TRIMED, INC. (9031076)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- July 5, 2007
- Registered through
- 2027
- Brand names listed
- ASET Foot Plating System, Distal Xtremities System, EOS Small Bone Fixation System, K-wires, Large Compression Screws, Medoff Small Fragment Clamp/Buttress Pin, Omnitech EasyLock Osteosystem with Xtremities Plates, Omnitech Large or TriMed Compression Screw and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Broach | HTQ | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Countersink | HWW | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Driver, Surgical, Pin | GFC | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Impactor | HWA | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Bending Or Contouring | HXP | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Compression | HWN | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Nail, Fixation, Bone | JDS | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Passer | HWQ | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Pin, Fixation, Smooth, Metallic | NDL | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Prosthesis, Finger, Constrained, Polymer | KYJ | 2 | Complaint file establishment | accessdata.fda.gov |
| Reamer | HTO | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Rod, Fixation, Intramedullary And Accessories | HSB | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Staple, Fixation, Bone | JDR | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Template | HWT | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Washer, Bolt Nut | HTN | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Washer, Bolt, Nut, Non-Spinal, Metallic | NDG | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 12, 2026 | K262344 | Large Compression Screws | HWC | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| July 16, 2026 | K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| May 14, 2026 | K261241 | TriMed Compression Screws | HWC | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| January 15, 2026 | K254002 | TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13-7S); TriMed Volar Bearing Plates (VBEAL-14-7S); TriMed Volar Bearing Plates (VBEAR-14-7S); TriMed Volar Bearing Plates (VBEAL-16-7S); TriMed Volar Bearing Plates (VBEAR-16-7S) | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| August 20, 2025 | K252061 | Distal Xtremities System | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| July 11, 2025 | K251134 | RipCord | HTN | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| July 10, 2025 | K251945 | TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| June 26, 2025 | K250929 | TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate); TriMed Ulnar Osteotomy System (Hex Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Locking Cortical Screw 3.2mm); TriMed Ulnar Osteotomy System (Lag Screw 3.2mm) | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| May 22, 2025 | K250935 | TriMed Fifth Metatarsal System (Fifth Metatarsal Plate); TriMed Fifth Metatarsal System (Fifth Metatarsal Screw) | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| April 10, 2025 | K243943 | TriMed® Compression Screws | HWC | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| April 8, 2025 | K250948 | TriMed Fusion Cup System | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| March 19, 2025 | K243999 | TriMed Ankle Fixation System | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| March 19, 2025 | K243987 | TriMed Elbow and Forearm System | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| January 15, 2025 | K243569 | TriMed Wrist Fixation System (Volar Bearing Plates); TriMed Wrist Fixation System (Volar Fixed Angle Plates); TriMed Wrist Fixation System (Hook Plates); TriMed Wrist Fixation System (Pin Plates); TriMed Wrist Fixation System (Peg Plates); TriMed Wrist Fixation System (Shear Plates); TriMed Wrist Fixation System (Wireform plates and Washer); TriMed Wrist Fixation System (Wireforms); TriMed Wrist Fixation System (Torx Cortical Screws); TriMed Wrist Fixation System (Torx Threaded Pegs); | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| November 26, 2024 | K243050 | TriMed Posterior Malleolus Fixation System | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| September 17, 2024 | K241942 | TriMed Bridge Plates | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| April 17, 2024 | K233863 | TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T- | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| January 18, 2024 | K234040 | TriMed Threaded Intramedullary Nail System | HWC | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| September 1, 2023 | K230805 | TriMed Clavicle Fixation System | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| April 17, 2023 | K230749 | TriMed Threaded Intramedullary Nail System | HWC | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| December 21, 2022 | K222637 | TriMed Wrist Fixation System 3 | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| June 1, 2022 | K220650 | TriMed Ripcord Device | HTN | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| August 6, 2021 | K211783 | TriMed Threaded Intramedullary Nail System | HWC | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| January 5, 2020 | K192696 | TriMed ASET Foot Plating System | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| July 1, 2019 | K190166 | TriMed Nitinol Staple System | JDR | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| September 21, 2016 | K161746 | ARIX Hand System | HRS | Substantially Equivalent | Jeil Medical Corporation | accessdata.fda.gov |
| January 29, 2016 | K151735 | TriMed Humeral Supracondylar Fixation System | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| April 17, 2015 | K140453 | OSTEOTEC SILICONE FINGER IMPLANT | KYJ | Substantially Equivalent | Osteotec, Ltd. | accessdata.fda.gov |
| December 18, 2013 | K132876 | ARIX HAND LOCKING SYSTEM | HRS | Substantially Equivalent | Jeil Medical Corporation | accessdata.fda.gov |
| May 10, 2012 | K112794 | EOS SMALL BONE FIXATION SYSTEM | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| November 4, 2011 | K112509 | TRIMED CLAVICLE FIXATION SYSTEM | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| August 19, 2011 | K102785 | TRIMED RADIOCARPAL FUSION SYSTEM | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| March 17, 2010 | K093676 | OMNITECH LARGE, TRIMED COMPRESSION SCREW | HWC | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| February 7, 2006 | K060041 | TRIMED BONE PLATES | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| July 27, 2005 | K050681 | OMNITECH SYSTEM & EASY LOCK OSTEOSYSTEM WITH XTREMITIES PLATES | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| January 14, 2005 | K043263 | TRIMED OSTEOTOMY PLATE | HRS | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| March 12, 2004 | K040112 | TRIMED BEARING PLATE; TRIMED VOLAR BEARING PLATE | HRS | Substantially Equivalent | Tri-Med, Inc. | accessdata.fda.gov |
| June 6, 2001 | K010545 | TBW | NDL | Substantially Equivalent | Tri-Med, Inc. | accessdata.fda.gov |
| June 27, 1995 | K951303 | SFC | HWC | Substantially Equivalent | Medpac | accessdata.fda.gov |
| May 5, 1995 | K951302 | SMALL FRAGMENT PLATES AND SCREWS | JDS | Substantially Equivalent | Medpac | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 19, 2024 | 94381 | Class II | Ongoing | TriMed, Threaded IM Nail 3.6mm, 60mm, TI, Ref: IMN3.6-60 T, Non Sterile, MD, Rx Only TriMed, Threaded IM Nail 3.6mm, 65mm, TI, Ref: IMN3.6-65 T, Non Sterile, MD, Rx Only | Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque. | accessdata.fda.gov |
| November 28, 2023 | 93748 | Class II | Ongoing | Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an | Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes. | accessdata.fda.gov |
| December 22, 2022 | 91478 | Class II | Ongoing | RipCord Syndesmosis Button, REF: STA001K | Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break. | accessdata.fda.gov |
| September 28, 2018 | 83820 | Class II | Ongoing | TriMed Countersink 1.7mm, HCS, REF HSINK-1.7, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA. | The epoxy on Apex manufactured epoxy-coated instruments can pop off. | accessdata.fda.gov |
| August 24, 2018 | 83563 | Class II | Terminated | TriMed Dorsal Wrist Hook Plate, Dorsal, 4-Hole, REF WHD-4, contained in a tray, insert, or poly package containing varying amounts, Nonsterile, Single Use Only, Rx. The firm name on the label is TriMed, Santa Clarita, CA | Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device. | accessdata.fda.gov |
| August 24, 2018 | 82209 | Class II | Terminated | TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a | The bone screw is shorter than the intended design specification. | accessdata.fda.gov |
| August 15, 2018 | 83984 | Class II | Terminated | TriMed Olecranon Hook Plate, Lt, 6-Holes, REF: OHOOKL-6, Non-Sterile, RX only, (01) 00842188101281 - Product Usage: The OHOOKL is a semi-tubular design bone plate with two offset intramedullary tines, which are intended | The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified. | accessdata.fda.gov |
| April 16, 2018 | 80487 | Class II | Terminated | Ulnar Osteotomy Compression Plate, Short Model: UOCP-S Product Usage: The UOCP-S is provided non-sterile with the required fixation screws and surgical instrumentation. The TriMed Ulnar Osteotomy Plate is intended for us | Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate | accessdata.fda.gov |
| April 13, 2018 | 80099 | Class II | Terminated | Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19 | During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if | accessdata.fda.gov |
| January 11, 2018 | 79224 | Class II | Terminated | Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number HXDRIVR-2.5CL AO; Hex Driver Part Number DVHX-2.5/130C AO; Hex Driver Part Number HXDRIVR-3.0 AO; Hex Driver Part Numb | Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy. | accessdata.fda.gov |
| August 29, 2016 | 75080 | Class II | Terminated | TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or | TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted. | accessdata.fda.gov |
Compare with other makers
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- All makers of Screw, Fixation, Bone
- All makers of Guide, Surgical, Instrument
Updated August 12, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.